MAUDE Adverse Event Report: ETHICON INC. ARTISYN Y-SHAPED MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number	ARTY
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Fistula (1862); Pain (1994); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Ethicon mdr summary reporting exemption e2013037 reporting period april 1, 2018 through may 31, 2018 (b)(4) total number of events ¿ 35; artisyn y-shaped mesh -1 ; gynecare gynemesh ps -34 (b)(4).
Event or Problem Description
It was reported by an attorney that the patient underwent a gynecological surgical procedure on (b)(6) 2015 and the mesh was implanted.Following the procedure, the patient experienced pain, erosion of her internal bodily tissue and vesicovaginal fistula.The patient underwent a mesh excision surgery on (b)(6) 2017.No further information is available.
Additional Manufacturer Narrative
Pc-(b)(4).Date sent to fda: (b)(4) 2018.Ethicon mdr summary reporting exemption e2013037 reporting period (b)(4) 2018 through (b)(4) 2018.
Additional Manufacturer Narrative
Date sent to fda: 12/28/2018 ethicon mdr summary reporting exemption e2013037 reporting period june 1, 2018 through july 31, 2018 supplemental 02 - attachment: [08-31-2018 oto supplemental 02.Xlsx].
Additional Manufacturer Narrative
Date sent to fda: 4/24/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 02/11/2019.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 2/18/2020.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 04/20/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.
Additional Manufacturer Narrative
Date sent to fda: 02/22/2021.Ethicon mdr summary reporting exemption e2013037.Reporting period june 1, 2018 through july 31, 2018.

• Brand Name: ARTISYN Y-SHAPED MESH
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7787917
• Report Number: 2210968-2018-75204
• Device Sequence Number: 11374313
• Product Code: OTO
• UDI-Device Identifier: 10705031218475
• UDI-Public: 10705031218475
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2015
• Device Model Number: ARTY
• Device Catalogue Number: ARTY
• Device Lot Number: GM8GGPB0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 12/28/2018; 02/11/2019; 04/24/2019; 02/18/2020; 02/22/2021; 04/20/2021
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/25/2018; 12/28/2018; 02/11/2019; 04/24/2019; 02/18/2020; 02/22/2021; 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR